NEW YORK (Reuters Health) – For patients with inadequately controlled asthma, the combination of mometasone furoate and formoterol reduces exacerbations and slows the decline in lung function more that either component alone, a multicenter team reports in the European Respiratory Journal online August 4.

“In this study, subjects receiving mometasone furoate/formoterol reported significant and clinically meaningful improvement in asthma control, QoL, and need for rescue medication,” the authors comment.

Dr. Eli O. Meltzer, with the Allergy and Asthma Medical Group and Research Center in San Diego, California and colleagues note that clinical trials have shown that asthma control is improved when a long-acting beta-agonist (LABA) is added to inhaled corticosteroid (ICS) therapy.

Individually, the LABA formoterol and the potent ICS mometasone furoate are effective asthma treatments, they add, and the current study assessed the effects of combining the two agents.

The investigators randomly assigned 746 patients with asthma not well controlled on low-dose ICS to one of four treatment groups: mometasone/formoterol 100/10 mcg, mometasone 100 mcg, formoterol 10 mcg, or placebo, administered by metered-dose inhaler BID for 26 weeks.

The incidence of asthma deterioration (ie, severe exacerbation) during the study period was 17% in the mometasone/formoterol group, 28% in the mometasone-only group, 45% among those receiving formoterol only, and 46% in the placebo group, the researchers report.

The value of the formoterol component on lung function was demonstrated by the change in 12-hour area-under-the curve for FEV1: it was 4.00 L x h with the mometasone/formoterol combination compared with 2.53 L x h with mometasone alone, the team found.

The most frequent treatment-related adverse events were pharyngolaryngeal pain (0.8%), upper respiratory tract infection (0.7%), and headache (0.7%). Serious adverse events in 11 subjects were all considered unrelated to study medication, Dr. Meltzer and colleagues report.

Mometasone furoate/formoterol 100/10 mcg, they conclude, “was well tolerated and a more efficacious overall asthma treatment than either of its components in subjects not well controlled on low-dose ICS monotherapy, with both mometasone furoate and formoterol contributing to the therapeutic efficacy of the combination product.”

In June 2010, the US Food and Drug Administration (FDA) approved the combination of mometasone furoate and formoterol fumarate dihydrate as Dulera inhalation aerosol (Merck & Co, Inc) in strengths of 100/5 mcg and 200/5 mcg per actuation.

Reference:
Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function
Eur Respir J 2011.